Amneal Pharmaceuticals of New York, LLC recalls Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals
Recalled November 24, 2021 · FDA recall D-0233-2022 · Amneal Pharmaceuticals of New York
Hazard
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. · FDA Class II
Units
7,766 bottles
Sold at
Product was distributed nationwide within the United States
Description
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Product
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
Manufacturer(s)
Amneal Pharmaceuticals of New York, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →